FDA Approval
FDA Device Meetings
FDA Device Meetings Any meeting with the FDA on it’s White Oak campus can be intimidating, but a FDA device meeting to assess both pre-market…
E-Cig Rule Practical Guide
FDA E-Cig Rule Practical Guide Now that the shock of the new FDA E-Cig rule (Deeming Rule) is settling in it is time to get…
Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS)
FDA ENDS The FDA deeming rule extended authority over Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS). There are several key requirements that will go…
FDA E-Cigarette Rule Finalized
The FDA e-cigaratte rule finalized. That is the breaking update from the FDA on Thursday May, 5 2016. The new rule known as the “deeming”…
FDA Microneedling Presentation
FDA Microneedling This past month I joined the American Society for Aesthetic Plastic Surgery (ASAPS) for their annual conference. This year the ASAPS conference was held…
Amazon Registration Certificates and Seller Support
Amazon Registration Certificate A recent post on Amazon Registration Certificates generated a number of questions along with shared frustrations. In the previous post, I talked…
FDA Exemption to E-Cigarette Deeming Rule
***UPDATE December 16, 2016*** The draft text of the Omnibus Bill does not include the FDA exemption to e-cigarette deeming rule. If this is confirmed,…
FDA Picamilon Status
In the FDA’s most recent set of warning letters Picamilon noticeably stood out with five (5) firms receiving a FDA Warning Letter on the same…
FDA Holiday Imports
The time is fast approaching where US shoppers will begin their holiday shopping. FDA holiday imports are a common feature of the holiday season in…
Regulatory Planning for FDA FY 2016
The FDA operates on a Federal Fiscal Year rather than a calendar year. The FY runs from October 1 through September 30. The new FY brings…
FDA Microneedling Regulations Status Update
Befuddled and Confused – Microneedling and the FDA One of the most common questions received in our office is whether a product is “FDA Approved.”…
510k Exempt Medical Device Guidance
510k Exempt Medical Device Guidance New Guidance Expands Class I and II Exemption to Devices Previously “Unclassified” or “Reserved” New 510 Exempt medical device Guidance…